Acceptability of Palliative Care in Parkinson Disease Care

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Christopher Tarolli，University of Rochester

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

May 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral[ Time Frame: 3 months ]

We will assess the feasibility of standardized referral to palliative care by calculating the proportion of enrolled participants with Parkinson disease who have at least 1 visit with a palliative care provider within 3 months of referral.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change in mean symptom burden[ Time Frame: Baseline to 3 months ]
Symptom burden will be measured using the Edmonton Symptom Assessment Scale-Revised for Parkinson Disease (ESAS-R: PD), which measures the severity of 14 symptoms on a 1-10 scale. Scores range from 0-140 with higher scores indicating higher symptom burden.
Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD)[ Time Frame: Baseline to 3 months ]
Quality of life will be measured using the Quality of Life-Alzheimer Disease questionnaire, which is a 13-item measure that assesses overall quality of life with a focus on physical, social, psychological, and spiritual well-being. Scores range from 13-52 with higher scores indicating better quality of life.
Change in mean caregiver burden[ Time Frame: Baseline to 3 months ]
Caregiver burden will be measured using the Zarit Burden interview, which is a 22-item questionnaire that assesses caregiver fear, anger, guilt, perspective, hope, and overall quality of life. Scores range from 0-88 with a score of 0-21 associated with little or no burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, and 61-88 severe burden.
Change in mean caregiver self-efficacy[ Time Frame: Baseline to 3 months ]
Caregiver self-efficacy will be measured using the Revised Scale for Caregiver Self-efficacy, which is a 15-item questionnaire with 3 sub-sections (self-efficacy for obtaining respite, self-efficacy for responding to disruptive patient behaviors, and self-efficacy for controlling upsetting thoughts about caregiving). Respondents rate their certainty of being able to complete each task from 0% (cannot perform task at all) to 100% (certain that task can be performed). Scores on each of the sub-sections range from 0-500 with a higher score indicating greater self-efficacy.
Barriers to palliative care referral[ Time Frame: Baseline ]
Barriers to palliative care referral will be measured using a novel qualitative survey that assesses perceived barriers to referral and drivers of desire for referral to palliative care among those with Parkinson disease. The measure includes a qualitative survey of 9 potential barriers to consultation and 5 potential reasons to undergo consultation. Respondents can select as many barriers or reasons as applicable to their perception of referral and can provide free text responses. Overall frequency of selection of each identified barrier among participants will be assessed both at baseline and at 3 months following palliative care referral. Barriers and reasons for referral with higher frequency will be considered to be more important in hindering or driving desire for referral, respectively.
Barriers to palliative care referral[ Time Frame: 3 months ]
Barriers to palliative care referral will be measured using a novel qualitative survey that assesses perceived barriers to referral and drivers of desire for referral to palliative care among those with Parkinson disease. The measure includes a qualitative survey of 9 potential barriers to consultation and 5 potential reasons to undergo consultation. Respondents can select as many barriers or reasons as applicable to their perception of referral and can provide free text responses. Overall frequency of selection of each identified barrier among participants will be assessed both at baseline and at 3 months following palliative care referral. Barriers and reasons for referral with higher frequency will be considered to be more important in hindering or driving desire for referral, respectively.

Descriptive Information

Brief Title ^ICMJE

Acceptability of Palliative Care in Parkinson Disease Care

Official Title ^ICMJE

Pilot to Assess the Acceptance of Palliative Care Referral Among Those With Parkinson Disease

Brief Summary

This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. The specialty focuses on providing relief from the symptoms and stress of serious illness.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Palliative Care referral
Individuals with Parkinson disease identified as having specific uncontrolled symptoms or critical events will undergo standardized referral to palliative care, who will provide supportive care. During the palliative care referral, participants and their care partners may discuss symptoms, disease burden (physical, emotion, financial, and psychological), quality of life, goals of care, and advance directive completion. Palliative care specialists may recommend interventions to manage bothersome symptoms or to improve disease burden for both participants and care partners.

Study Arms

Experimental: Palliative Care referral
Participants with specific uncontrolled symptoms or critical events in course of their Parkinson disease will be referred to a palliative care specialist for supportive care.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 1, 2019

Estimated Primary Completion Date

May 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Subjects with Parkinson disease: Inclusion Criteria: - Diagnosis of idiopathic PD confirmed as most likely diagnosis with participant's treating provider - 18 years of age or older - Participant or care partner able to provide informed consent - Presence of one or more of the following: Uncontrolled symptoms (over prior week): - Depression - Pain - Fatigue Critical events (over prior 6 months): - ≥3 falls - Unintended weight loss - Wheelchair dependence (>50% of time) Exclusion Criteria: - Diagnosis of atypical or secondary parkinsonism - Outpatient palliative care visit scheduled or within the prior 6 months of the screening visit Subjects who are care partners: Inclusion Criteria: - Care partner of enrolled participant in the study - 18 years of age or older - Able to provide informed consent Exclusion Criteria: • No care partner specific exclusion criteria

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Christopher Tarolli，University of Rochester

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Rochester

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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